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临床试验/NCT04893200
NCT04893200已完成不适用

Could Radiomics Predict Tumor Spread Through Air Space in Lung Adenocarcinoma in All Computed Tomography Settings?

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

Spread through air space (STAS) has been reported as a negative prognostic factor in patients with lung cancer undergone sublobar resection. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics has been recently proposed to predict STAS in patients with lung adenocarcinoma. However, all the studies have strictly selected both imaging and patients, leading to results hardly applicable to daily clinical practice. The aim of this study is to test a radiomics-based prediction model of STAS in practice-based dataset and verify its validity and translational potentials.

Radiological and clinical data from 100 consecutive patients with resected lung adenocarcinoma were retrospectively collected for the training section. As in common clinical practice, preoperative CT images were acquired independently by different physicians and from different hospitals. Therefore, our dataset presents high variance in model and manufacture of scanner, acquisition and reconstruction protocol, endovenous contrast phase and pixel size. To test the effect of normalization in highly varying data, preoperative CT images and tumor region of interest were preprocessed with four different pipelines. Features were extracted using pyradiomics and selected considering both separation power and robustness within pipelines. After that, a radiomics-based prediction model of STAS were created using the most significant associated features. This model were than validated in a group of 50 patients prospectively enrolled as external validation group to test its efficacy in STAS prediction.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with suspected or cito-histologically proven lung adenocarcinoma undergoing lung cancer surgery;
  • Available preoperative CT images
  • Age older than 18 years

排除标准

  • Chest wall infiltration
  • Induction radio or chemotherapy
  • Incomplete surgical resection

结局指标

主要结局

Sensitivity

时间窗: 24 hour before operation

Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve

Specificity

时间窗: 24 hour before operation

Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Anile

Principal Investigator

University of Roma La Sapienza

研究点 (1)

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